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Patient Considerations in the Management of Rheumatoid Arthritis: Role of Once-A-Month Golimumab Injection

机译:类风湿关节炎的患者考虑因素:每月一次戈利木单抗注射剂的作用

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Golimumab (GLM) is a fully human monoclonal antibody with amino acid sequences of the light and heavy chains identical to those of infliximab, that binds specifically to both the soluble and transmembrane bioactive forms of human TNF-?, thereby inhibiting the biological activity of TNF. GLM was studied in an extensive program of RCTs that included one study in phase I and one in phase II, and studies in phase III including patients failing MTX (GO-FORWARD), failing other anti TNF (GO-AFTER), MTX na?ve patients (GO-BEFORE), and one study with IV GLM in patients that remained active in spite of receiving MTX. These studies showed that GLM is effective and safe for the treatment of RA, with a efficacy and safety profile very similar to the other classic anti TNF biologics, and determined the approval by the FDA in April 2009 for use in moderately-to-severely active RA in combination with methotrexate (MTX) when given to adults. In comparison to other biologics for RA, GLM has some advantages: first, it's less frequent administration (every 4 weeks); and second, its subcutaneous route of administration, which allows patients to self administer the drug at home. Currently, GLM represents an option to RA active patients desiring less frequent injections and to patients in whom the previous treatment with other TNF-? inhibitors failed.
机译:Golimumab(GLM)是一种完全人类单克隆抗体,其轻链和重链氨基酸序列与英夫利昔单抗相同,可特异性结合人TNF-α的可溶性和跨膜生物活性形式,从而抑制TNF的生物学活性。 。在一项广泛的RCT计划中对GLM进行了研究,其中包括一项I期研究和II期研究,以及III期研究,包括MTX(GO-FORWARD)失败,其他抗TNF(GO-AFTER),MTX失败的患者。 ve患者(GO-BEFORE),以及一项针对IV GLM的研究,该研究针对尽管接受MTX仍保持活跃的患者。这些研究表明,GLM对RA的治疗有效且安全,其功效和安全性与其他经典抗TNF生物制剂非常相似,并于2009年4月获得FDA批准用于中度至重度活性成人时,RA与甲氨蝶呤(MTX)联合使用。与RA的其他生物制剂相比,GLM具有一些优势:首先,它的给药频率较低(每4周一次);第二,其皮下给药途径,使患者能够在家中自行给药。目前,GLM对于希望减少注射频率的RA活跃患者以及以前接受过其他TNF-α治疗的患者而言,是一种选择。抑制剂失败。

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